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510(k) K885235

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. by Spectramed, Inc. — Product Code DSK

K885235 is an FDA 510(k) premarket notification submitted by Spectramed, Inc. for the device "SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.". The FDA issued a decision of Substantially Equivalent on January 25, 1989. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Spectramed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1989
Date Received
December 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Spectramed, Inc.

  • K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED (January 19, 1990)
  • K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267 (November 6, 1989)
  • K895323 — MODEL DT-BAL, BALANCE SAVER (October 24, 1989)
  • K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (August 15, 1989)
  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (September 28, 1988)
  • K875337 — HEPARIN COATED LUMINAL PACING CATHETER (May 25, 1988)
  • K880740 — MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (March 22, 1988)
  • K873168 — SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (January 12, 1988)
  • K871573 — CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS (September 16, 1987)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources